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Acetaminophen by NCS HealthCare of KY, Inc dba Vangard Labs

Medically reviewed on Jan 15, 2018

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-4510

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Acetaminophen Tablet 500mg

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purposes

Pain Reliever/Fever Reducer

Aspirin Free Extra Strength Pain Reliever

Uses

for the temporary relief of minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen 
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Do not use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)

adults and children 12 years and over:

  • take 2 tablets every 6 hours while symptoms last.
  • do not take more than 6 tablets in 24 hours unless directed by a doctor
  • do not take for more than 10 days unless directed by a doctor

children under 12 years: ask a doctor

Other information
  • Store at room temperature

Inactive ingredients

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions or comments?

Call (800) 616-2471

Distributed By: MAJOR® PHARMACEUTICALS,

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA

Rev. 11/16 M-95

Principal Display Panel

 

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-4510(NDC:0904-1988)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE 
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A CORN 
STEARIC ACID 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUND (round flat faced beveled edge) Size12mm
FlavorImprint CodeGPI;A5
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-4510-3930 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/04/2011
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-4510), REPACK(0615-4510)

 
NCS HealthCare of KY, Inc dba Vangard Labs

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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